Psi Health Solutions, Inc. FDA Record
- Latest inspection VAI · Sep 9, 2015
- No warning letters matched by name
Psi Health Solutions, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Psi Health Solutions, Inc." is on file.
- Latest inspection
- Sep 9, 2015 · VAI
- Latest 510(k)
- Jul 26, 2007
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 9, 2015 | Pacific Grove, CA | Devices | Voluntary Action Indicated (VAI) | 3006236731 |
| Apr 13, 2012 | Pacific Grove, CA | Devices | No Action Indicated (NAI) | 3006236731 |
| May 24, 2010 | Pacific Grove, CA | Devices | No Action Indicated (NAI) | 3006236731 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3006236731 | Pacific Grove, CA | 3 | Sep 9, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K070766 | PSI BANDS | Jul 26, 2007 |
Psi Health Solutions, Inc. and the FDA: common questions
Has Psi Health Solutions, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Psi Health Solutions, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Psi Health Solutions, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Psi Health Solutions, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Psi Health Solutions, Inc.?
The most recent FDA inspection on file ended Sep 9, 2015 at Pacific Grove, CA and was classified VAI. FDA has 3 inspections of Psi Health Solutions, Inc. on file.
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